• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
DeviceSILIKON 1000
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
6201 south freeway
mail drop r7-14
fort worth, TX 76134-2099
PMA NumberP950008
Supplement NumberS007
Date Received05/04/2009
Decision Date10/30/2009
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications of specification ranges for viscosity and molecular weight. The current specifications for viscosity and molecular weight are 900 ¿ 1,250 cs and 32,850 ¿ 47,000 daltons, respectively. The proposed regulatory acceptance specifications for viscosity and molecular weight are 980 ¿ 1,350 cs and 31,000 ¿ 44,500 daltons, respectively.